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FRAZER, Pa.—Cephalon Inc. announced in late February that it exercised its option to acquire Ception Therapeutics Inc., after a significant clinical study with an investigational antibody showed positive results in adults with eosinophilic asthma.
A Phase II clinical trial of Ception's lead compound, CINQUIL, in the study's 106 patients showed improved asthma control in adult patients with moderate to severe asthma and eosinophilic airway inflammation.
"This study showed a strong treatment signal and compelling internal consistency on the effect of CINQUIL on measurements of asthma and lung function," says Dr. Lesley Russell, chief medical officer at Cephalon. "These data provide confidence that CINQUIL shows a meaningful treatment effect in this patient population. We look forward to advancing CINQUIL into Phase III clinical trials."
CINQUIL is an investigational humanized monoclonal antibody against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role in the maturation, growth and movement within the body of eosinophils, which are inflammatory white blood cells implicated in a number of allergic diseases including asthma. This investigational agent is currently administered as an intravenous injection; a subcutaneous formulation is being developed.
Eosinophilic asthma is a type of severe asthma with persistent inflammation of the airways associated with increased levels of eosinophils. There is an increasing body of evidence that asthma is a heterogeneous disease, with eosinophilic airway inflammation a common feature among its various manifestations.
Although inhaled corticosteroids have long been a treatment of choice for particularly difficult breathing problems related to asthma, there is a subgroup of patients with severe asthma in whom eosinophilic airway inflammation persists despite therapy with high doses of inhaled corticosteroids. Patients with eosinophilic asthma may experience changes in their airways, impaired lung function, more frequent asthma exacerbations and near-fatal asthma attacks. Such patients are in need of additional anti-inflammatory therapies to address persistent high levels of eosinophils and associated poor prognosis.
Based on these Phase II results, Cephalon exercised its option to acquire Ception on Feb. 22.
The merger agreement is subject to customary closing conditions, including expiration of applicable antitrust waiting periods. Upon the closing of the merger, Cephalon would purchase all of the outstanding capital stock of Ception for $250 million, subject to adjustment for any third party debt held by Ception. Ception shareholders could receive additional payments related to clinical and regulatory milestones.
"The acquisition of Ception is consistent with our strategy to diversify into biologics and provides us with an important Phase III asset for further development," says Dr. Frank Baldino, Jr., chairman and CEO of Cephalon.
The four-month, double-blind, placebo- controlled involved adult patients who received CINQUIL or placebo administered intravenously once every 28 days for four cycles. Patients entering the study were required to have persistent asthma symptoms, despite high doses of inhaled corticosteroids, and elevated eosinophils in their sputum. Patients on CINQUIL showed an improvement on breathing tests compared to the group that received a placebo.
The antibody improved white cell count in the sputum of patients in the study. The study participants also did better on indices that measure airway obstruction or other breathing difficulties. Fewer patients in the trial group who received CINQUIL as opposed to a placebo experienced clinic asthma exacerbations, such as airway constriction, emergency room visits or a course of oral steroids.
Cephalon will further evaluate the study data and work with the U.S. Food and Drug Administration to determine how to move clinical development of CINQUIL forward to Phase III study.
Cephalon is an international biopharmaceutical company and has a reputation for going after the most intriguing and obstinate medical conditions. Since its inception in 1987, the company has discovered, developed and brought to market medicines to patients around the world in several therapeutic areas. Cephalon has a growing presence in Europe, the Middle East and Africa. Cephalon Europe markets more than 30 products in 50 countries in four therapeutic areas: central nervous system, pain, primary care and oncology.
Ception is focused on the discovery and development of novel products to address areas of unmet medical need. In addition to its work on CINQUIL, it brings to the table an established program to discover small molecule, orally-active, anti-TNF (tumor necrosis factor) receptor agents.